Nystatin
- Product NDC
- 66689-008
- 11-digit product format
- 666890008
- Labeler code
- 66689
- Product ID
- 66689-008_beaf5815-9659-4ba3-ac23-6e734f4afc05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- VistaPharm, Inc.
- Application
- ANDA064142
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/mL
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-008-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | 41034d7b-33a1-4d6d-b425-9cfefff8d518 |
| 66689-008-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | 41034d7b-33a1-4d6d-b425-9cfefff8d518 |
| 66689-008-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1c06-111a-e063-dadaa90a10e2 | 41034d7b-33a1-4d6d-b425-9cfefff8d518 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-008-02 | ML - Milliliter | 66689-008 | e63a7936-f9a8-4bfe-bce4-ea8756f5be60 | 1 | 2013-03-03 |
| 66689-008-16 | ML - Milliliter | 66689-008 | 96d8d758-76b3-4bd8-bb50-b0ffa58d8df4 | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312055 | nystatin 100,000 UNT/mL Oral Suspension | PSN | 5a07151e-0a9f-4ca5-b7b2-d954e8c33a27 | 1 |
| 312055 | nystatin 100000 UNT/ML Oral Suspension | SCD | 5a07151e-0a9f-4ca5-b7b2-d954e8c33a27 | 1 |
| 312055 | nystatin 100,000 UNT/ML Oral Suspension | SY | 5a07151e-0a9f-4ca5-b7b2-d954e8c33a27 | 1 |
| 312055 | nystatin 500,000 UNT per 5 ML Oral Suspension | SY | 5a07151e-0a9f-4ca5-b7b2-d954e8c33a27 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66689-008-02 | 66689000802 | 60 mL in 1 BOTTLE (66689-008-02) | 60 ml | 2012-05-01 | 0000-00-00 | No | No | Current |
| 66689-008-08 | 66689000808 | 237 mL in 1 BOTTLE (66689-008-08) | 237 ml | 2012-05-01 | 0000-00-00 | No | No | Current |
| 66689-008-16 | 66689000816 | 480 mL in 1 BOTTLE (66689-008-16) | 480 ml | 2012-05-01 | 0000-00-00 | No | No | Current |